Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

National Institute on Aging (NIA)

National Cancer Institute (NCI)

Funding Opportunity Title
Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed)
Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type
Reissue of PAR-19-254
Related Notices
  • NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
  • NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
  • April 11, 2022 - Notice of Informational Webinar on NIGMS Technology Development Program Funding Opportunity Announcements (PAR 22-126 and PAR 22-127). See Notice NOT-GM-22-034.

Funding Opportunity Announcement (FOA) Number
PAR-22-126
Companion Funding Opportunity
PAR-22-127 , R01 Research Project
Assistance Listing Number(s)
93.859, 93.394, 93.866
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) supports exploratory research leading to the development of innovative technologies for biomedical research that is relevant to the NIGMS mission or that of other NIH Institutes or Centers (ICs) participating in this FOA. Projects should entail a high degree of risk and/or novelty, which will be offset by a high future potential impact in biomedical research. Outcomes or products of the proposed project, which should significantly advance the current state of the art, may include, but are not limited to:

  • laboratory instruments and other devices,
  • algorithms and software,
  • chemical reagents and processes,
  • biological molecules or systems that have been modified by human intervention to become research tools.

The goal of this FOA is to support proof of concept, high-risk and potentially high-reward studies for feasibility and exploratory technology development. Due to the constraints that would be imposed on broad utility, this FOA does not support technology development that is narrowly focused on addressing specific biological questions. Rather, applications should propose development of innovative tools that can potentially benefit a broad spectrum of biomedical research. Moreover, feasibility of the proposed technology must not have already been established in the literature or with preliminary data. Applications that are focused on technology development to address specific biological questions and/or include unpublished or published data that provide proof of concept are not responsive to this FOA and will be administratively withdrawn without review.

Key Dates

Posted Date
March 21, 2022
Open Date (Earliest Submission Date)
May 16, 2022
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 16, 2022 * Not Applicable September 07, 2022 * November 2022 January 2023 April 2023
October 16, 2022 * Not Applicable January 07, 2023 * March 2023 May 2023 July 2023
February 16, 2023 * Not Applicable May 07, 2023 * July 2023 October 2023 December 2023
June 16, 2023 * Not Applicable September 07, 2023 * November 2023 January 2024 April 2024
October 16, 2023 * Not Applicable January 07, 2024 * March 2024 May 2024 July 2024
February 16, 2024 * Not Applicable May 07, 2024 * July 2024 October 2024 December 2024
June 16, 2024 * Not Applicable September 07, 2024 * November 2024 January 2025 April 2025
October 16, 2024 * Not Applicable January 07, 2025 * March 2025 May 2025 July 2025
February 16, 2025 * Not Applicable May 07, 2025 * July 2025 October 2025 December 2025

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
May 08, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Support for Early-Stage Technology Development Is Critical to Advancing Biomedical Research

Technological advances are crucial for accelerating biomedical research. Technology enables science by providing new ways to address questions, and more importantly, by allowing researchers to pose new questions that could not be anticipated in the absence of the enabling technology. New knowledge drives the imperative for new tools, and those tools open new questions, in a mutually reinforcing positive feedback loop that drives science forward. Early technology development can be described in two stages: (I) exploratory proof-of-concept research to determine the feasibility and best approach(es) for a technology development project, and (II) the subsequent research and development that focuses exclusively on creating and validating a working prototype technology before application to untested biomedical problems is possible. This FOA invites projects in Stage I — evaluation of an untested concept. A companion FOA, PAR-22-127 “Focused Technology Research and Development (R01- Clinical Trial Not Allowed)” supports projects in Stage II - research and development of a working prototype. Applications that include technology development projects to address specific biological questions are not responsive to the goals of these FOA but may be submitted through the Parent R01 funding announcement or other FOAs (e.g., NIGMS' Maximizing Investigators' Research Awards).

Applications to this FOA should propose technology development at a conceptual stage, not yet supported by any proof-of-concept-data, in order to demonsetrate feasibility of the proposed technology and/or establish the most likely path to successful development. When compared to current state-of-the-art technology, the proposed concept should lead to a technological breakthrough, or a significant advance in current biomedical research or approaches. The project’s starting point should be the current state of knowledge and concepts must not have been tested for feasibility. Project aims should focus on either: (a) exploratory research to identify, among several possibilities, the approach with the highest likelihood of success, or (b) demonstrating feasibility of a specific novel approach.

For this FOA, technology refers to tools, methods and techniques that enable a broad spectrum of biomedical research that falls within the NIGMS mission or in that of the ICs participating in this FOA including, but not limited to:

  • laboratory instruments and other devices,
  • algorithms and software,
  • chemical reagents and processes,
  • biological molecules or systems that have been modified by human intervention to become research tools.

Further, this FOA calls for innovative exploratory technology development predicated on an explicitly described broad need or challenge in biomedical research. This need should exceed current technological capability, with the state-of-the-art technological performance defining the starting point. Comparison of the proposed technical performance improvement to the state of the art will provide the rationale for developing a fundamentally different technology. Specific well-characterized test systems may be used for validation, but applications should highlight the broad utility of the technology for biomedical research. Applications that include investigation of specific biological questions in the time frame of the proposed project are considered nonresponsive to this FOA and will be administratively withdrawn without review.

Responsiveness Criteria

Proof of Concept: This FOA supports proof-of-concept studies to develop prototypes and exploratory technology that do not have demonstrated feasibility in the literature, are not based on preliminary data, and are not obvious extensions of the current state of the art. The expected project outcome should be a clear test of concept, either positive or negative. The proposed concept should be innovative, represent a significant advance over the state of the art, and address current obstacles to advancing biomedical research.

Validation: Application to synthetic models or well-characterized biological systems to assess performance can be included at this stage. To be considered for funding, applications of the technology must be limited to test systems chosen to facilitate technology development rather than to immediately address biological questions. The project aims must be focused entirely on the technology development.

Non-Responsiveness Criteria

Biological Questions: Applications that include aims that address specific biological questions are not responsive to the goals of this FOA and will be administratively withdrawn without review. However, validation of a technology against known standards is encouraged. Although biomedical relevance is an essential element of NIH research, this stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions.

Information that establishes feasibility or proof of concept: Applications that include published or unpublished results that support the feasibility of the Specific Aims, forecast the project objectives, develop proof of concept or mitigate risk are not responsive to the goals of the FOA and will be administratively withdrawn.

Relevance of Research Topics for this FOA

Prospective applicants are strongly advised to consult with the relevant Scientific/Research Contact(s) listed in this FOA for guidance on assessing the application's relevance for this FOA. Final determination of application eligibility for this FOA will be based on NIH Staff assessment of the full application after submission. Applications that are determined to be non-responsive to this FOA, or that propose research topics that are not appropriate for the participating NIH institutes, will be administratively withdrawn.

Participating NIH Institute Missions

NIGMS: The mission of NIGMS is to support basic research that increases our understanding of biological processes and lays the foundation for future advances in disease diagnosis, treatment, and prevention. NIGMS-funded scientists investigate how living systems work at a range of levels - from molecules and cells to tissues and organs - in research organisms, humans, and populations. The institute’s research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS also supports the development of fundamental methods and new technologies to achieve its mission. Supported research may utilize specific cells or organ systems if they serve as models for understanding general principles.

NIGMS supports:

  • research and technology development that is aimed at understanding general principles, mechanisms, and processes through Scientific Divisions with diverse interests,
  • research in specific clinical areas that affect multiple organ systems such as anesthesiology and peri-operative pain, sepsis, clinical pharmacology that is common to multiple drugs and treatments, trauma, burn injury, and wound healing.

NIGMS does not support:

  • research focused on single classes of cells, tissues, organs, or diseases unless they are used as models for elucidating basic principles,
  • technology development for a specific disease and/or organ system beyond the specific ones listed above,
  • HIV/AIDS-related applications.

Prospective applicants are encouraged to visit NIGMS Technology Development Programs (R21 and R01) for more details.

NIA: The mission of NIA is conducting and supporting research on aging and the health and well-being of older people. NIA supports technologies which will increase the understanding of the nature of aging and the aging process, and diseases and conditions associated with growing older, in order to extend the healthy, active years of life.

NCI: The mission of NCI is to lead, conduct, and support cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. NCI is interested in technology development projects which can ultimately enable novel and improved cancer diagnostic capabilities and treatment strategies. Examples of focused research areas include, but are not limited to:

  • Synthetic biology devices to advance understanding of cancer biology with a goal of improving cancer diagnosis and treatment,
  • Nanotechnologies capable of biological discovery,
  • Tools to enable deep tissue ex vivo and in vivo imaging and integration,
  • Next-generation non-invasive cancer molecular diagnostics platforms beyond tissue biopsies,
  • In vitro imaging diagnostic technologies,
  • Liquid biopsy technologies with the goal of improving cancer diagnosis and treatment,
  • Technologies for the detection and evaluation of cancer of unknown primary (CUP),
  • Technologies for neoantigen identification, including dendritic cell-displayed antigens and neoantigens.

Note: Applications that propose technology development with the following characteristics will be of low funding priority:

  • incremental advance of technology,
  • obvious substitution of one known element for another,
  • technology that will only lead to an incremental advance in biomedical research,
  • combinations of prior elements with additive utility,
  • technologies that are ready for advanced development and validation.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to a total of $275,000 Direct Costs over the two-year project period. No more than $200,000 Direct Costs may be requested in any single year. (Direct cost limits exclude consortium F&A costs.) The budget must be well justified and reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Specific Aims should propose to advance the technical knowledge required to investigate or manipulate biological systems in the service of furthering basic biomedical research that is supported by the participating NIH institutes. Technical advances should be novel, inventive entities or methods that have future utility to broadly advance biomedical research. Examples would include instruments, devices, processes, algorithms, software, chemicals, biomolecules, or cells that have potential value for enabling new biomedical research.

Research Strategy:

Significance

In addition to the topics outlined in the SF424 (R&R) Application Guide, describe the potential impact of the tool that will be developed. Describe the proposed technical advance over the state of the art and the future biological applications that would be enabled by the new technology. Limitations of the state of the art provide the rationale for developing a fundamentally different technology. Because this is very early-stage exploratory technology development, the impact is not likely to be immediate. Nonetheless, the possible future impact of the proposed technology must be compelling and clearly articulated.

Innovation

In addition to the topics outlined in the SF424 (R&R) Application Guide, outline the unique nature of the technical opportunity that will be exploited in the project. The technology concept should be novel, inventive entities or methods with potential broad utility for biomedical research. Innovation could be evaluated by the amount of technical advance over the state of the art and/or the potential advance enabled in current biomedical research or approaches.

Approach

In addition to the topics outlined in the SF424 (R&R) Application Guide, describe those aspects of the experimental approach that are specific to exploratory technology development. These include the uncertainties underlying the proposed technology research and development, including the risk of failure.

Provide the rationale for the approach or approaches to be explored in the project. Describe how feasibility or proof of concept for the technology will be established. Outline how data will be obtained, analyzed, and interpreted with sufficient rigor to quantitatively assess project outcomes. Identify the project performance that would be required to achieve high reward in the objectives and milestones. While inclusion of untested biological questions will not be funded, validation of the nascent technology with well-characterized models or gold standard biological samples is encouraged.

Project objectives should be novel and not obvious compared to the current state of the art, as evidence that the concept is achievable would demonstrate positive proof of concept which is not allowed in this FOA. To ensure that feasibility or proof of concept has not been evaluated, do not include or refer to unpublished and/or preliminary data, results, or conclusions, since these forecast an increased likelihood of success.

Published data for establishing the state of the art and/or justifying the proposed work can be provided through literature citations, published data from other sources including preprints with a DOI number, or theoretical principles. Any published data that forecast the success of the project objectives or develop proof of concept are not responsive to the FOA.

Objectives and Milestones: Describe the desired characteristics of the technology at the conclusion of the project as end-point objectives, and present intermediate milestones towards that goal. Direct the milestones toward addressing the fundamental questions regarding the selection of an appropriate path forward for continued development of the technology once the project is completed. The milestones and objectives are measurable project performance criteria that, if achieved, would be a significant increment of technical advance over the state of the art. Describe how experimental results from the exploratory project will serve as a foundation for next phase development efforts such as R01, small business grants, or equivalent. For exploratory research, high risk is expected, and milestones might not be reached on a predictable timetable. Nonetheless, define measurable milestones and state whether intermediate or end-point project performance would be adequate for further technical development of working prototypes. For exploratory research, it is expected that further technical improvement would be necessary to achieve biomedical research utility. Describe the desired performance characteristics of the proposed technology and specific measures that will be used to evaluate progress toward achieving those goals. Limit applications of the technology to validation against synthetic models or well-characterized biological systems. Explain the rationale for the selection of test systems in terms of the desired technology performance and how a test system will facilitate technology development.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness, compliance with application instructions and responsiveness to the FOA by the Center for Scientific Review and the participating ICs. Applications that are incomplete, non-compliant or non-responsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.

The Exploratory Research for Technology Development program uses the R21 activity code but is distinguished from the NIH Parent R21 in several important respects. Projects should be justified with a strong potential to enable biomedical research if successful. Appropriate justification for the proposed work can be provided through literature citations, published data from other sources including preprints with a DOI number, or theoretical principles. However, projects should focus exclusively on technology development that is at the initial concept stage and has not yet been proven. Because projects will not yet have been evaluated for feasibility, it should be expected that they might have a high risk of failure. The project should focus on exploratory research that, at its conclusion, would evaluate the feasibility of one or more technical approaches. Projects referring to unpublished or preliminary data supporting feasibility or proof of concept are not appropriate for this program. Unpublished data must not be included and proof of concept or feasibility must not have been established. Any preexisting data should be part of the state of the art, which serves as the baseline for innovative advances. Significant projects should have both innovative technical advances and compelling utility for future biological research. Biological validation with known well-characterized systems is encouraged, but applications that include investigation of specific biological questions are not responsive to this FOA.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Does the proposed technology development have the potential to address substantial unmet needs in biomedical research? Will the proposed technology, if developed, constitute a technological advance or solve a longstanding technical problem?

If the technology is successfully developed in the future, is it likely to have significant broad utility for biomedical research?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: Is the proposed technology novel, inventive, or non-obvious compared to the technical state of the art? Does the application propose a proof-of-concept or a feasibility study that has not already been developed in published or unpublished results? If successful, would the technology enable novel or inventive biomedical questions to be answered?

Is the application ambitious, with well identified risk, rather than incremental? Will the project take a fundamentally new approach?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Is the project focused on demonstrating proof of concept for an unproven idea? Will the proposed work produce preliminary data, proof of concept, and/or determine feasibility of the proposed technology? Are the uncertainties underlying the proposed technology and risk of failure adequately described. Will the data collection and analysis process enable quantitative assessment of the project outcomes?

Is the technology performance validated with well-characterized synthetic models or biological samples appropriate for early stage research? If the project is intended to determine the most appropriate technological approach among multiple alternatives, would completion of the proposed research plan yield necessary and sufficient preliminary data to make that determination?

Are the intermediate and end-point objectives or milestones well defined? Are the scientific rigor, data analysis, and interpretation adequate to evaluate whether objectives or milestones have or have not been met? Would experimental results from the exploratory project serve as a foundation for next phase development efforts such as R01, small business grants, or equivalent?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review,
  • Availability of funds,
  • Relevance of the proposed project to program priorities,
  • Institute portfolio diversity.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

As part of the RPPR, grantees are expected to report any accomplishments of the award leading to:

  • Grant applications to programs such as the SBIR/STTR
  • Dissemination of tools and technologies to other research laboratories or as commercialized products
  • Patent applications and awards

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

To evaluate the success of the NIGMS Technology Development R21 Program, NIGMS may request information essential to an assessment of the program effectiveness from databases and participants themselves. After the award ends, participants may be contacted for periodic updates on their publication activities, support from additional research grants or contracts, and other information helpful in evaluating the program's impact. Within ten years of making awards under this program, NIGMS will assess the program’s overall outcomes, gauge its effectiveness in encouraging technological innovations to further biomedical research, and consider a continued need for the program. Upon completion of this evaluation, NIGMS will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

Overall program evaluation will be based on metrics that will include, but are not limited to, the following:

  • Aggregate number and demographic characteristics of applicants and awardees including applicant’s home department, institution, and/or career progression,
  • Grant applications to programs such as the SBIR/STTR or other independent research funding programs,
  • Dissemination of tools and technologies to other research laboratories or as commercialized products,
  • Patent applications and awards.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Alvin Yeh, Ph.D.
Division of Biophysics, Biomedical Technology and Computational Biosciences
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_techdev@nigms.nih.gov

Kadir Aslan, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences (NIGMS)
Email: NIGMS_techdev@nigms.nih.gov

Piotr Grodzinski, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3305
Email: grodzinp@mail.nih.gov

For question on cancer in-vitro imaging and molecular diagnosis

Miguel R. Ossandon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: ossandom@mail.nih.gov

Leonid Tsap, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7747
Email: leonid.tsap@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Jennifer Billington
National Institute of General Medical Sciences (NIGMS)
Email: billingj@mail.nih.gov

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: jessi.perez@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.